Integrating Risk-based Care for Patients With CKD

NCT03365063 | Terminated

• 1 other identifier: H2017:050
• Study Type: interventional
• Target: 5,600
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic kidney disease (CKD) and its end stage of kidney failure are major public health problems in Canada and worldwide. In the primary care setting, accurate prediction of the risk of kidney failure in patients with CKD can improve patient provider communication, assist in appropriate nephrology referral, improve dialysis treatment planning, and identify patients who are most likely to benefit from intervention. To aid in accurately predicting the risk of kidney failure requiring dialysis in patients with CKD, the primary investigator has developed and validated the kidney failure risk equation (KFRE), which is increasingly used in nephrology practices across Canada and the United States. In this current study, a cluster randomized controlled trial (RCT) will be done in collaboration with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Primary care clinics that can integrate the KFRE into their electronic medical records will be randomized to receive the intervention (patients and providers receive individualized information explaining kidney failure risk, as well as risk-based criteria for referral, alongside usual care) versus usual care alone (no information on personalized risk and no risk-based referral). In both groups, the investigators will assess management of patients at high risk of kidney failure (patient), timing of referral for patients at high risk of kidney failure (health system), cost of CKD care (health system), CKD-specific health literacy (patient), trust in physician care (patient), and satisfaction with risk prediction tools (provider). The objective of this research study is to develop, implement, and evaluate tools to guide the care of patients with CKD in the community, including appropriate referral using a risk-based approach. Specifically, this study will address the question: "Does providing patients (and their physicians) with information about their risk of kidney failure improve quality of care, health literacy, and trust in the care they are receiving?"

Conditions

Chronic Kidney Disease

Keywords

Knowledge Translation; Chronic Kidney Disease; Matched Cluster Randomized Trial

Outcome Measures

Primary Outcomes (2)

• Proportion of CKD patients in each clinic who have albuminuria (albumin-creatinine ratio (ACR)) tested

  This will be determined using data extracted from each clinic's EMR.

  1 year after intervention

• The percentage of patients who are appropriately managed with an ACEi or ARB, and who either have CKD and diabetes, or who have CKD and a urine ACR >30 mg/mmol.

  This will be determined using data extracted from each clinic's EMR.

  1 year after intervention

Secondary Outcomes (10)

• Diabetes management for CKD patients

  1 year after intervention

• Hypertension management for CKD patients

  1 year after intervention

• Management of cardiovascular risk factors for CKD patients

  1 year after intervention

• Appropriate medication usage

  1 year after intervention

• eGFR function for CKD patients

  2 years after intervention

Study Arms (2)

Active Knowledge Translation Group

EXPERIMENTAL

Primary care clinics receiving the active knowledge translation intervention.

Other: Active Knowledge Translation

Control Group

NO INTERVENTION

Primary care clinics receiving the current standard of care. Information on personalized risk and risk-based referral will not be provided.

Interventions

Active Knowledge Translation OTHER

1. Integration of the KFRE in the CPCSSN DPT - The DPT will report the output from the KFRE for all patients with CKD Stages G3-G5 from the clinic sites. The risk output will include interpretation and automated categorized risk of progression to kidney failure, and will recommend actions based on the KFRE risk based care pathway. 2. Audit and Feedback - Providers at CPCSSN clinics receive sentinel feedback reports on a panel of chronic conditions and quality improvement targets. The investigators will add CKD to the feedback report for the intervention sites, and provide detailed feedback on the practices' risk profile. 3. Medical Detailing - The intervention CPCSSN clinics will receive a standardized presentation to clinic staff by the principal investigator, who will provide the evidence for the accuracy of the KFRE and guidance on implementation of a risk based treatment pathway, as well as describe the supporting visual aids.

Active Knowledge Translation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care clinics in Manitoba and Alberta who provide care to adults in the community and use an EMR that can integrate the KFRE and its associated decision aids for CKD management and referral.
• All patients with CKD Stages G3-G5 who attend the 32 clinics.

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Primary Care Sentinel Surveillance Network: collaborator
• Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease: collaborator
• Manitoba Primary Care Research Network (MaPCReN): collaborator
• Southern Alberta Primary Care Research Network (SAPCReN): collaborator

Study Sites (2)

Southern Alberta Primary Care Research Network (SAPCReN)

Calgary, Alberta, T2N 4N1, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (3)

• Harasemiw O, Drummond N, Singer A, Bello A, Komenda P, Rigatto C, Lerner J, Sparkes D, Ferguson TW, Tangri N. Integrating Risk-Based Care for Patients With Chronic Kidney Disease in the Community: Study Protocol for a Cluster Randomized Trial. Can J Kidney Health Dis. 2019 May 29;6:2054358119841611. doi: 10.1177/2054358119841611. eCollection 2019.

  PMID: 31191908 BACKGROUND

• Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill A, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble S, Mangin D, Drummond N. Prevalence and Demographics of CKD in Canadian Primary Care Practices: A Cross-sectional Study. Kidney Int Rep. 2019 Jan 21;4(4):561-570. doi: 10.1016/j.ekir.2019.01.005. eCollection 2019 Apr.

  PMID: 30993231 BACKGROUND

• Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill AK, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble KS, Mangin D, Drummond N. Quality of Chronic Kidney Disease Management in Canadian Primary Care. JAMA Netw Open. 2019 Sep 4;2(9):e1910704. doi: 10.1001/jamanetworkopen.2019.10704.

  PMID: 31483474 BACKGROUND

Related Links

• Study Website

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Navdeep Tangri, MD PhD FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 7, 2017
• Study Start: August 24, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

CA (2)